Agency classClass IOur severity:Critical FDA (Devices)·Z-0442-2016·Announced 2015-12-30

Biomerieux Etest PIP/TAZO/CON-4 PTC 256 Recalled for Erroneous Results

Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC 256 antimicrobial susceptibility tests due to the potential for reporting false susceptible results for Piperacillin/Tazobactam.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I, which mandates a severity score of 5 (Critical) according to the rubric.

Plain-English summary

Biomerieux is recalling 2,422 units of Etest PIP/TAZO/CON-4 PTC 256, a quantitative technique used to determine the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria. The recall is due to the potential for reporting erroneous results, specifically false susceptible results, for Piperacillin/Tazobactam.

The affected product is identified by Reference 521458 and includes specific lot numbers: 1004397280, 1004271100, 1003977350, 1003903650, 1003561810, 1003239850, 1002489700, 1002273480, 1002216620, and 1002120370. The product was distributed worldwide, including nationwide in the United States and in numerous international countries.

Healthcare facilities and laboratories should stop using the affected lots and contact Biomerieux for instructions on returning the product. This recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

Product: Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
Manufacturer: Biomerieux
Category: Medical Device — Laboratory Diagnostic
Hazard: mis-labeling
erroneous-results
Affected units: 2,422

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

Ref. 521458
Lot numbers: 1004397280
1004271100
1003977350
1003903650
1003561810
1003239850
1002489700
1002273480
1002216620 and 1002120370.

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Biomerieux under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Biomerieux

See all →

Severe
Biomerieux Recalls Etest Piperacillin/Tazobactam Tests Due to False Results
FDA (Devices) · 2015-12-30
Severe
Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC Antimicrobial Susceptibility Tests
FDA (Devices) · 2015-12-30
Severe
Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC 256 Antimicrobial Susceptibility Tests
FDA (Devices) · 2015-12-30
Low
Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date
FDA (Devices) · 2014-11-26
Low
Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date Labeling
FDA (Devices) · 2014-11-26

Same hazard · mis labeling